Cleared Traditional

K041563 - OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS

K041563 · Glaxosmithkline Consumer Healthcare, L.P. · Dental device
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
78d
Days
-
Risk

K041563 is an FDA 510(k) clearance for the OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS. Classified as Saliva, Artificial (product code LFD).

Submitted by Glaxosmithkline Consumer Healthcare, L.P. (Parsippany, US). The FDA issued a Cleared decision on August 27, 2004 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Glaxosmithkline Consumer Healthcare, L.P. devices

FDA 510(k) Submission Details - K041563

510(k) Number K041563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2004
Decision Date August 27, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 128d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 44
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K041563.
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SALINUM, ORCLAIR
K024148 · Sinclair Pharmaceuticals, Ltd. · Sep 2003
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
K981693 · Gebauer Co. · Aug 2001
CAPHOSOL ARTIFICIAL SALIVA
K991938 · Inpharma A.S. · Aug 1999